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Guidance: Regulating medical devices from 1st January 2021 in Great Britain, Northern Ireland and the EU

On 1st September, 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published its latest Guidance outlining the requirements for placing medical devices on the markets of Great Britain (England, Scotland and Wales), Northern Ireland (NIR) and the European Union (EU) respectively. The guidance provides some insight into how certain aspects of the UK’s system will operate,
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UK’s new dedicated Yellow Card reporting site

The UK is determined to display full information for users of medical devices, and it is undoubtedly trying to grant them the most effective security as well. To this end, a new reporting site has recently been set up; the Yellow Card reporting site. While being engaged in full-steam negotiations with the EU for the
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How does Brexit affect the commercialization of your cosmetic products?

Regardless the outcome of the ongoing EU trade negotiations, Brexit will imply certain consequences for economic actors. In particular, because even if a free trade agreement is concluded between the UK and the EU, the above does not provide for internal market concepts (in the area of goods and services) such as mutual recognition, the
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Spanish Agency on labelling of medical device in case of Brexit

The Spanish Agency of Drugs and Medical Devices (AEMPS) has established a transition period until June 302020 to give manufacturers more time when changing service providers in view of Brexit. The AEMPS had already released a guidance (PS, 8/2019) in April 2019 on the most important aspects to be taken into account once Brexit takes
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The latest news on the approval process of the UK Medical Device law

The latest news on the approval process of the UK Medical Device law As COVID-19 keeps troubling the world, Brexit negotiations appear to be on hold. In fact, EU trade talks could be postponed due to the coronavirus. Nevertheless, the new UK law on Medical Devices has lately been progressing through the chambers at Westminster.
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What are the implications of Brexit for Medical Device Companies up to December 31, 2020?

The Irish Health Products Regulatory Authority (HPRA) has recently issued a brief explanation of the impact that Brexit will have upon medical devices during the transitional period, namely until December 31, 2020. The UK officially left the EU on January 31, 2020, after having reached an agreement with the EU on October 17, 2019. However,
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Brexit – Last update

With the whole of Europe at expenses of the outcome, the European Parliament is about to issue its final decision with regards to the wording of the revised UK Withdrawal Agreement and Political Declaration. While on 23 January 2020 the EU constitutional affairs committeee voted positively and recommended to the European Parliament to approve the
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Brexit – Belgian Ministry of Health dedicated website

At expenses of Brexit becoming effective, the Belgian Ministry of Health has provided through its dedicated website some important answers, worth reading for every manufacturer placing its devices on the UK market/using UK EC RP or a UK Notified Body. In addition, if you are concerned about possible shortages of certain medical devices due to
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BREXIT: What happens now?

December 2019 - January 2020: Parliament votes on Boris Johnson's Brexit deal. During Christmas period the UK MPs will be called back to discuss to pass legislation – Boris Johnson’s Brexit deal –  in the form of the Withdrawal Agreement Bill allowing to meet the January 31st deadline to take the UK out of the
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Is the Irish health sector prepared for an eventual Brexit?

If you are an Irish undertaking producing or exporting medical devices into the European Union or you are simply willing to extend your market, this article is for you. It is a fact that the Irish Health Products Regulatory Authority is in close cooperation with its correlative Department of Health to plan, alongside stakeholders from
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Spain is ready for Brexit: new checklist for Medical Devices and Cosmetics

The Spanish Agency of Medicines and Medical Devices (AEMPS) has published a Checklist to verify the Brexit readiness of companies based in Spain in the sector of: Medical Devices: Devices with a Notified Body (NB) established in the UK: manufacturer must ask for a new Certificate from a EU27 NB or for the transferal of
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Brexit & EU product legislation: What to expect?

Undoubtedly, the departure of the UK from the European Union (EU) will cause a major shift in the industry sector and the related EU product legislation. On 19th January 2018, the European Commission published an official Notice to Stakeholders [Withdrawal of the United Kingdom and EU rules on company law] presenting the new rules on
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How will cosmetic products be regulated in the UK in case of a no-deal Brexit?

Preparing for different Brexit scenarios, the UK government published a guidance covering the EU Exit Regulation for Cosmetic Products in case UK leaves the European Union without a deal. While there are many similarities between the EU and UK regulatory regime for cosmetic products, the withdrawal of the UK from the European Union without a
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Update on Brexit: Cosmetics

On the 18th of July, the European Commission published a Notice to stakeholders regarding the withdrawal of the United Kingdom and the impact on the EU rules in the field of cosmetic products. Consequences for cosmetic products As of the withdrawal date, which is set so far for the 1st of November 2019, the UK
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Brexit preparedness in case of a no-deal scenario

With only 8 weeks remaining, European authorities are finalizing preparations for the withdrawal of the United Kingdom from the European Union. Considering the approaching deadline, the European Commission has published its 6th Brexit preparedness communication. The European Commission sends a strong message to all stakeholders including those in the medical device industry to prepare for
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UK Government publishes EU Exit Regulation for Medical Devices

As the UK is preparing its withdrawal from the European Union, EU law is currently being converted into a new type of domestic (UK) law. The type of law that will become effective in the UK on the exit day, currently scheduled on October 31st2019, is called “retained EU law”. By removal of the constitutional
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MHRA Official Guidance on How Medicines, Medical Devices and Clinical Trials Would Be Regulated If There’s No Brexit Deal

March 29th 2019 is fast approaching, and the UK is  currently facing to leave the EU without a deal in place. For this  reason, the UK government has been publishing technical notices for  businesses and citizens to understand what to expect in a no deal  scenario. We will focus on the recently published MHRA official
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Official EU Notice on BREXIT

On November 29th 2018, the European Commission (Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs) published an official notice to stakeholders in reference to NEW EU rules in the field of cosmetic products in relations to the Withdrawal of the United Kingdom from the European Union. Download Official Notice – Click Here Why now? In
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Obelis UK Ltd established!

We are happy to announce that on 27th of December 2018 Obelis has officially established a new company in the UK – Obelis UK Ltd. The purpose of this company is to serve as a UK Responsible Person for our clients, who will need a representative in the UK in the case of a ‘no
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